In order to implement the Opinions On Deepening Reform of Review and Approval System and Encouraging Innovation of Drug and Medical Device (TZ [2017] No. 42) and Opinions of the State Council on the Reform of Drug and Medical Device Review and Approval System (GF [2015 No. 44]) issued by the General Office of the CPC Central Committee and the General Office of the State, strengthen the management on the registration of vitro diagnostic reagents, and standardize the clinical assessment of vitro diagnostic reagents that are exempted from clinical trials, the basic requirements on clinical evaluation data for IVD Reagents for the exempted clinical trials (Trial) is developed by China Food and Drug Administration in accordance with the Administration of IVD Reagent Registration (Decree No. 5 of the CFDA), and is hereby issued and implemented from the date of issuance.

Appendix: the basic requirements on clinical evaluation data for IVD Reagents for the exempted clinical trials (Trial)

China Food and Drug Administration

November 3, 2017

Interpretation on the Issuance of the basic requirements on clinical evaluation data for IVD Reagents for the exempted clinical trials (Trial)

Main contents:

The scope of application, basic requirements, clinical evaluation methods, trial methods, clinical evaluation reports, and other evaluation materials, which describes the basic requirements on clinical trials and relevant requirements on application materials. Detailed contents are as follows:

(1). The applicant's main responsibilities are emphasized. The applicant may complete the clinical evaluation in China independently or by entrusting other agencies or laboratories. The trial should be controlled by the applicant, the evaluation report should be signed by the applicant / agent, and the authenticity of the trail data is the responsibility of the applicant.

(2). The requirements on traceability of sample sources are emphasized. The original information of sample (case) for evaluation should include at least the sample source, unique and traceable number, age, gender, type of sample, and clinical background information of the sample.

(3). The trial methods of clinical evaluation are specified. The applicant may carry out the trial by following the guiding principle of methodology comparison, and carry out the statistical analysis by using appropriate statistical methods based on product characteristics to obtain objective and reliable results.